BEUDAMED
    FDA Adverse Event Injury Summary report: N

    I-STAT TROPONIN (CTNI) CARTRIDGE

    MDR report key: 3935573 · Received July 15, 2014

    Report

    Report Number
    2245578-2014-00032
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 21, 2014
    Report Date
    June 23, 2014
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    MMI
    PMA / PMN Number
    K031739
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION WAS COMPLETED ON 07/15/2014. RETURN PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION. HOWEVER, RETAIN CARTRIDGES WERE TESTED AND ARE FUNCTIONING ACCORDING TO SPECIFICATION.

    Description of Event or Problem · 1

    ON (B)(6) 2014, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT RESULT OF 3.3 ON A (B)(6) YEAR OLD FEMALE PATIENT THAT PRESENTED WITH SHORTNESS OF BREATH. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. DATE TIME METHOD RESULT SAMPLE(B)(6) 2014 22:55 I-STAT 3.3 A(B)(6) 2014 04:00 VISTA 0.015 B(B)(6) 2014 03:40 VISTA 0.015 C(B)(6) 2014 09:30 I-STAT 5.4 D SAMPLE WAS DRAWN TWO HOURS PRIOR TO TESTINGTHE CUSTOMER PROVIDED NEW INFORMATION ON (B)(4) 2014 THAT THE PATIENT WAS CATHETERIZED BASED ON ONLY ONE POSITIVE I-STAT TROPONIN RESULT (3.3), CHANGE IN THE PATIENT PULSE RATE AND EKG WHICH SHOWED IRREGULAR SINUS RHYTHM. THE PROCEDURE DETERMINED THE PATIENT DID NOT EXPERIENCE A MYOCARDIAL INFARCTION.THERE WERE NO INJURIES REPORTED WITH THIS EVENT. AN INVESTIGATION IS UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412721 I-STAT TROPONIN (CTNI) CARTRIDGE CTNI CARTRIDGE MMI ABBOTT POINT OF CARE NA P14075

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Disability